Business
Sun BioPharma, Inc. Provides a Business Update and Files Report for Q2 2019
Sun BioPharma, Inc. Provides a Business Update and Files Report for Q2 2019.
About this update from Panbela Therapeutics, Inc.
[{"type":"text","content":"\nEnrollment in Third Cohort of PDA Combination Study is Encouraging                              Preliminary Efficacy Signals Improve with New Data Regarding Second CohortEntire $2.3 million Owed under Convertible Notes Converted to Equity MINNEAPOLIS, Aug. 13, 2019 (GLOBE NEWSWIRE) -- Sun BioPharma, Inc. (OTCQB: SNBP), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of pancreatic diseases, today provides a business update and reports financial results for the quarter ended June 30, 2019.\n Front-Line Combination Pancreatic Cancer Dose Escalation StudyThe Company’s second clinical trial, a Phase 1a/1b combination of SBP-101 with gemcitabine and nab-paclitaxel in patients previously untreated for metastatic pancreatic ductal adenocarcinoma (“PDA”) began dosing patients in the third and final dose level cohort in mid – July, immediately following a review of cohort two data and approval by the Data Safety Monitoring Board (“DSMB”). The Phase 1a portion of this study is planned to have a total of 3 dosing levels and determine a recommended dose of SBP-101 to be given in combination with standard treatment. The protocol for the next phase of this study, originally planned for just ten patients, was recently expanded to 36. The Company completed enrollment of an expanded second cohort during the quarter ended June 30, 2019. Encouraging signals of efficacy have been noted in the second cohort. Six of 6 evaluable subjects (100%) had significant decreases in Tumor Marker CA19-9 levels during treatment, ranging from 75% to 95%. The CA19-9 level improvements were accompanied by Response Evaluation Criteria in Solid Tumors (“RECIST”) assessments of 4 partial responses and 2 subjects with stable disease at that interim analysis. Subsequent to the review of second cohort data by the DSMB an updated RECIST tumor assessment on one subject was changed from stable disease to partial response, resulting in interim efficacy RECIST assessments of 5 partial responses and 1 stable disease, for an overall response rate of 83% at dose level 2. Michael T. Cullen, MD, Executive Chairman, President and CEO commented, “We are delighted with the observed response rates to this ...